Progeny I7016, Руководство пользователя

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General Information JB-70
6
EC Declaration of Conformity
Name and
Description of
Product Progeny JB-70
Catalog
Model
I7017, 76 inch reach, 120Volt
30-A0001, Control, 120Volt
30-A2025, Extension Arm, Long
Catalog
Model I7016, 66 inch reach, 120Volt
30-A0001, Control, 120Volt
30-A2034, Extension Arm, Short
Catalog
Model I7027, 76 inch reach, 230Volt
30-A0003, Control, 230Volt
30-A2025, Extension Arm, Long
Catalog
Model I7026, 66 inch reach, 230Volt
30-A0003, Control, 230Volt
30-A2034, Extension Arm, Short
Class: IIb
Reference
Numbers to
which
Conformity is
Declared
The following regulatory documents apply:
21CFR
UL 2601-1
IEC 60601-1-2
IEC 60601-1-3
IEC 60601-2-7
IEC 60601-2-28
IEC 60601-2-32
Medical Device directive
ISO 13485
EN46001
Declaration
Progeny, Inc. declares that the products described herein meet all the applicable
Essential Requirements of the EC Medical Device Directive 93/42/EEC in Annex
I. For Class IIb products described herein, the product is manufactured,
inspected, tested and released in accordance with the approved quality
assurance system established in accordance with ISO 9001, EN 46001 and
Annex II of the EC Medical Device Directive under the Supervision of the British
Standards Institution, a Notified Body carrying the Notified Body No. 0086.
Contact Alan Krema
Product Development
Progeny, Inc.